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Vaxxas Gets $20M Injection to Test Needle-Free Vaccines in Humans

What’s the worst part of getting vaccinated? Most folks, outside of the anti-vaccination crowd, would probably say the needle prick. A startup named Vaxxas is one of a group of companies trying to get rid of the ouch factor, and today it just got a big round of cash to see if its approach works in human beings.

Vaxxas, a startup with operations in Cambridge, MA, and Australia, has raised a $20 million Series B round to continue developing what it calls the Nanopatch; a method of delivering vaccines through a small skin patch, not a needle. The cash is coming from “new and existing investors.” Vaxxas isn’t disclosing the specific investors in the new round, but its existing backers include OneVentures, Brandon Capital, HealthCare Ventures, and the Medical Research Commercialisation Fund, an investment entity supported by the Australian government.

The raise comes as Vaxxas is hitting the most critical point in its development. Later this year, it’ll finally begin testing its technology in humans. According to CEO David Hoey, that first trial will likely be of a skin patch version of the flu vaccine. If Vaxxas can show that the vaccine can safely elicit a potent immune response, the kind that a traditional vaccine can produce (or ideally a better one), it’ll help validate the company’s plans to apply its technology to vaccines for polio, bacterial infections—even cancer.

“We’re sort of shifting gears,” Hoey says.

Vaxxas started up in 2011, based on work out of Mark Kendall’s lab at Queensland University in Australia. That work led to the Nanopatch: a device, about a square centimeter in size, that looks like sandpaper to the naked eye. The patch is covered with tens of thousands of ultra-tiny spikes that can deliver doses of a vaccine to immune cells just under the skin. It’s administered via a spring-loaded applicator, and is supposed to deliver enough vaccine to induce a potent immune response—despite using one-hundredth the volume of vaccine of the typical injection.

The technology has a few key selling points. First, these patch-loaded vaccines are stable at room temperature because Vaxxas develops special formulations that are dried onto the patch’s little spikes. This sets it apart from most vaccines, which have to be kept cold. That’s not necessarily a big deal in the U.S., which has the so-called “cold chain” infrastructure to keep vaccines refrigerated from manufacturing to shipment to storage at a clinic or hospital. But a slew of developing countries lack such infrastructure, limiting the reach of life-saving immunizations–that’s part of the reason Vaxxas got funding support from the World Health Organization last year to develop a polio vaccine using the Nanopatch, Hoey says.

The second value add is getting rid of the needle and the ouch factor. Hoey says the Nanopatch feels like a “tap” on the skin. And he also claims that delivering a vaccine to the skin, rather than systemically via an injection, is more efficient—“most of the population of immune cells are directly beneath the skin,” he notes—so that should translate to a more potent response.

The approach got the attention of Merck, one of the world’s biggest vaccine makers, in 2012. After Vaxxas closed a $12 million Series A round, the two signed a deal that enabled Merck to tap into Vaxxas’s technology to convert one of its vaccines to skin patch product. It’s a typical licensing deal: Vaxxas got an (undisclosed) upfront fee, and was promised some milestone payments and royalties. Hoey won’t say what the status of that vaccine is or even what it treats (“the relationship is progressing,” he says), but deals like this are how Vaxxas envisions growing and making money. The company isn’t actually developing its own vaccines in-house—a costly, difficult venture for a startup. Rather, Vaxxas is scouting for marketed vaccines from larger companies, or experimental ones that smaller companies are developing, and which its technology might be able to improve. In the latter case, it might share the development costs and profits or even pay for full rights take on the clinical costs on its own.

This deal-centric focus is why Vaxxas established an office in Cambridge. While most of the company’s operations are still in Australia—all of its 25 employees and research work—Hoey spends most of his time in the biotech/pharma hotbed of Cambridge, doing outreach.

“Within 20 minutes of my house there’s about 50 percent of the world’s vaccine R&D,” he says.

Still, Vaxxas has some competition for partners, because it isn’t the only company with a needle-free vaccine technology. The FDA approved the first non-needle flu vaccine last year; it utilizes a jet injector developed by PharmaJet, of King of Prussia, PA. Other companies like Fremont, CA-based Zosano Pharma (NASDAQ: ZSPH); Menlo Park, CA-based Corium International (NASDAQ: CORI); and a unit of the conglomerate 3M; all have different microneedle-based approaches that can be used to deliver drugs. And others, like Cambridge-based startup Vaxess Technologies, are approaching the vaccine cold-storage problem with different solutions. Hoey says that there has been minimal penetration into the vaccine market, however—and it’s his contention that Vaxxas’s technology can generate a greater immune response than its competitors.

“People have not been doing head to head comparisons amongst patches, but if you look across the literature using comparable vaccines, the way we would extrapolate it is we think that our ability to be highly immunogenic is better than the other patches that we see in the market,” Hoey says.

That has to be proven, of course. Hoey is citing studies Vaxxas has done in rats and pigs; it has a prototype patch for humans, but it hasn’t been tested yet. That’s where the Series B cash comes in; it’ll fund Vaxxas’s first human study, in Australia, and should carry the company forward for the next three years.

“This puts us in a great position for the next couple of years,” Hoey says.

Ben Fidler is Xconomy's Deputy Editor, Biotechnology. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

This is a step towards safer vaccinations. The “anti-vaccination” crowd has legitimate concerns as they do not want to be contaminated with or exposed to dangerous ingredients, adjuvants and preservatives. All of which have been demonstrated as a cause for undesirable adverse reactions. Just read the “insert”! Using a patch can go a long way to limit this exposure.

My curiosity would be to see a complete list of ingredients that would transfer transdermally. Moreover, any long term studies would be worth reading. In nature, we are exposed to viruses. Not normally viruses plus additives. The safest vaccines would be those that emulate nature the closest. The needle-borne vaccines available to the general public are the least safe because they are practically nothing like what we’d be exposed to on a normal basis. Direct injection into the bloodstream with all the additives is madness.

Transdermal, comparitively speaking, seems like a lot better option. Let’s hope they don’t spike these with all the usual sterilants and neurologically embolizing agents.